Remotely Programmed Deep Brain Stimulation of the Bilateral Habenula for Treatment- Resistant Major Depression: An Open Label Pilot Trial

November 26, 2019 updated by: Bomin Sun, Ruijin Hospital

The habenula(Hb) is an epithalamic structure located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of studies indicates that that overactivity in the lateral habeluna(LHb) is present during depressed states, where it could drive the changes in midbrain activity linked to depression. Deep brain stimulation(DBS) of the major afferent bundle (i.e., stria medullaris thalami) of the LHb can treat treatment-resistant major depression(TRD). There is no clinical case of directly stimulating habeluna for treatment TRD. This research will investigate effectiveness bilateral DBS to habenula for patients with TRD.

Programming is a crucial aspect of DBS which directly influences its therapeutic efficacy. Researchers need to ascertain optimum stimulation parameters to help patients achieve optimal control of clinical symptoms. Remote programming of DBS can markedly improve patient convenience, minimize risk of infection and total treatment time and lead to an overall benefit for doctors and patients alike. This research will also investigate safety and benefit of remote programming of DBS.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Shanghai Ruijin Hospital Functional Neurosurgery
      • Shanghai, Shanghai, China
        • Shanghai Ruijin Hospital Functional Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-65 years old
  • Proficiency in Mandarin language;
  • DSM-IV diagnosis of Majior depression disorder;
  • Current episode duration ≥ 2 years;
  • Failure to respond to a minimum of four different antidepressant treatments;
  • Failure or intolerance of an adequate course of electroconvulsive therapy (ECT) during any episode;
  • Capacity to provide informed consent (understanding of the study purpose and methods);

Exclusion Criteria:

  • Schizophrenia or history of psychosis unrelated to MDD;
  • Antisocial personality disorder, dementia, current tic disorder;
  • Past stereotactic neurosurgical intervention;
  • Alcohol or substance abuse/dependence within 6 months;
  • Neurological disease (Abnormal PET-CT, MRI, EEG);
  • Contraindications of MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator;
  • Contraindications of stereotactic intervention, e.g. increased bleeding disposition, cerebrovascular diseases;
  • Serious and unstable organic diseases (e.g. unstable coronal heart disease);
  • HIV positive;
  • Pregnancy and/or lactation;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Deep Brain Stimulation
Device：Suzhou Sceneray® DBS system
Procedure: Bilateral surgical implantation of DBS system to Habeluna
The SceneRay DBS device utilized in the present study is a double-channel device designed and manufactured by Suzhou Scene-Ray Medical Co., Ltd. The DBS system includes a dual-channel neurostimulator kit, lead kit, extension kit, clinician-operated wireless programmer, test stimulator, and patient controller. The lead (diameter =1.27 mm) contains four stimulating contacts made of platinumiridium alloy. The length of each contact is 1.5 mm, and interval spaces are 0.5 mm. This device shares the same basic principles utilized by Medtronic products, with unique wireless programming and electrode fixing designs. The amplitude (0-10 V), pulse width (60-960 ms), and frequency (1-1,600 Hz) can be programmed, and different frequencies may be utilized in the left and right hemispheres using this type of dual-channel IPG.
Other: Follow-up Period
The researchers will remotely program the DBS biweekly after opening the stimulator and face to face test the patients' cognitive function every half year. Montgomery-Asberg Depression Rating Scale will be tested biweekly until the Programmed parameter has stable therapeutic efficacy and then tested after 3 months, 6 months, 9 months and 12 months.The other neuropsychological scales will be test on 3 months, 6 months, 9 months and 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the Montgomery-Asberg Depression Rating Scale
Time Frame: Baseline (preoperative),Biweekly after onset of the DBS system,3 months,6 months, 9 months, 12 months
Baseline (preoperative),Biweekly after onset of the DBS system,3 months,6 months, 9 months, 12 months
Change in the Hamilton Depression Scale
Time Frame: Baseline（preoperative）,3 months, 6 months,9 months, 12months
Baseline（preoperative）,3 months, 6 months,9 months, 12months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the Hamilton Anxiety Scale
Time Frame: Baseline（preoperative）,3 months, 6 months,9 months, 12months
Baseline（preoperative）,3 months, 6 months,9 months, 12months
Change in the Quality of Life Assessment (SF-36)
Time Frame: Baseline（preoperative）,3 months, 6 months,9 months, 12 months
Baseline（preoperative）,3 months, 6 months,9 months, 12 months
Neuropsychological measures(Scores of cogstate battery)
Time Frame: Baseline（preoperative）,6 months,12 months
Baseline（preoperative）,6 months,12 months
Change in the Hamilton Anxiety Scale
Time Frame: Baseline（preoperative）,3 months, 6 months,9 months, 12 months
Baseline（preoperative）,3 months, 6 months,9 months, 12 months
Change in the WHO-BREF
Time Frame: Baseline（preoperative）,3 months,6 months,9 months, 12 months
Baseline（preoperative）,3 months,6 months,9 months, 12 months
Change in Young Manic Rating Scale
Time Frame: Baseline (preoperative),Biweekly after onset of the DBS system,3 months,6 months, 9 months, 12 months
Baseline (preoperative),Biweekly after onset of the DBS system,3 months,6 months, 9 months, 12 months
Chang in Pittsburgh Sleep Quality Index
Time Frame: Baseline（preoperative）,3 months,6 months,9 months, 12 months
Baseline（preoperative）,3 months,6 months,9 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2017

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

August 16, 2017

First Submitted That Met QC Criteria

August 16, 2017

First Posted (Actual)

August 18, 2017

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Habenula DBS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Treatment Resistant Major Depressive Disorder

Clinical Trials on Bilateral surgical implantation of DBS system to Habeluna

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe